Senior Quality Engineer Quality Systems Engineer
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Job Location:
Milwaukee, WI - USA
Monthly Salary:
Not Disclosed
Posted on:
5 days ago
Vacancies:
1 Vacancy
Job Summary
Step into a role where your work directly supports safer stronger more reliable medical products. My client is looking for a Senior Quality Engineer who will play a key role in elevating quality systems strengthening compliance and driving meaningful improvements across a growing manufacturing environment. This is your chance to influence products that truly impact lives.
Why You Should Apply
- Opportunity to shape and improve critical quality systems in a regulated environment
- Meaningful impact supporting medical-grade products and customer programs
- High visibility role collaborating across engineering operations and leadership
- Competitive benefits and professional development support
What Youll Be Doing
- Lead improvements for CAPA complaints nonconformance audits training and validation
- Develop implement and enhance processes to meet quality and business metrics
- Analyze defective product trends and drive corrective actions using statistical tools
- Support customer collaborations supplier qualifications and change management
- Maintain documentation aligned with ISO 13485 and FDA QSR
- Lead investigations and develop effective CAPAs
- Conduct internal audits and support regulatory and customer audits
- Serve as Quality Lead when needed
About You
- Be able to do the job as described.
- Hold a bachelors degree in engineering or science
- Bring experience with ISO 13485 FDA 21 CFR 820 and regulated manufacturing
- Comfortable with statistical process control and process validation
- ASQ certification or Six Sigma training is a plus
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Niche executive search firm with 30+ years specializing in executive search and staffing in Medical Device, Biotech, Pharma, and Diagnostics. Jacobs Management Group is a WBENC certified retained and contingent search firm with 30+ years of industry success and a national network.
